ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

NCT ID: NCT04243668

Last Updated: 2023-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2023-06-30

Brief Summary

OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD)

DESIGN OF THE Prospective interventional study Sample size: 216

Detailed Description

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0

Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

Inclusion criteria

• Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
• Patients who are willing to pay the expenses of the ARMA procedure

Exclusion criteria

• Large Hiatal hernia >3cm
• Gr C/D esophagitis
• Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
• Paraesophageal hernia
• GE flap valve grade IV (Hill's classification)
• Barretts esophagus
• Esophageal dysmotility
• ASA physical status >II
• Previous esophageal or gastric surgery
• Pregnancy

Patients screening and inclusion:

The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.

Conditions

GERD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANTI REFLUX MUCOSAL ABLATION THERAPHY

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Group Type: EXPERIMENTAL

ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

Intervention Type: PROCEDURE

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

Interventions

ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)

In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.

Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI

• Patients who are willing to pay the expenses of the ARMA procedure

Exclusion Criteria

• • Large Hiatal hernia >3cm

• Gr C/D esophagitis
• Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
• Paraesophageal hernia
• GE flap valve grade IV (Hill's classification)
• Barretts esophagus
• Esophageal dysmotility
• ASA physical status >II
• Previous esophageal or gastric surgery
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Rakesh Kalapala

PRINCIPAL INVESTIGATOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nageshwar Reddy, DNB

Role: PRINCIPAL_INVESTIGATOR

Chairman

Locations

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Countries

India

References

Koduri KK, Singla N, Maragoni RG, Jagtap N, Singh AP, Kalapala R, Reddy DN. Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months. Indian J Gastroenterol. 2025 Oct;44(5):700-707. doi: 10.1007/s12664-025-01761-z. Epub 2025 Jun 11.

Reference Type: DERIVED

PMID: 40498286 (View on PubMed)

Other Identifiers

ARMA01

Identifier Type: -

Identifier Source: org_study_id